CN101466430A - Arrangement for introducing a liquid into the body of a patient - Google Patents

Abstract

The invention relates to an infusion device for infusing liquid into a patient's body or outputting liquid from a patient's body. The infusion set comprises a first part (1) with an injection cannula (2) protruding from the first part and a second part (3) with a coupling (5) for an infusion tube (6) interface (4). Furthermore, the first member (1) and the second member (3) are constructed and coupled to each other in such a way that they are inseparable, rotatable relative to each other and form a channel (7) at each rotationally relative position for access from the interface (4 ) to deliver liquid to the injection cannula (2) or to output liquid from the injection cannula (2) to the interface (4). In addition, the connection ( 4 ) is arranged on the second component ( 3 ) in such a way that the connection and disconnection of the corresponding coupling ( 5 ) always takes place transversely to the longitudinal axis of the injection cannula ( 2 ). As a result, an infusion set can be provided, which provides reliable safety against misuse while providing good carrying comfort.

Description

A device for infusing fluids into a patient

technical field

The invention relates to a device for the infusion of fluids into or out of a patient according to the preambles of the independent claims and to the use of said device for the subcutaneous infusion of medicinal fluids into a patient.

Background technique

For patients who consistently require drug administration by infusion directly into body tissue or the blood circulatory system, or for patients who must withdraw body fluid samples from the body for an extended period of time in order to monitor specific parameters such as blood It makes sense to do this with an injection cannula that is placed in place in the body and remains there for a relatively long time. Thus, at present, in patients with diabetes mellitus type I and type II, the infusion of the required amount of insulin is carried out in a continuous or uninterrupted manner by, under the control of an automated insulin pump, Insulin is supplied to an injection cannula that is inserted percutaneously into the patient's subcutaneous tissue and is part of a device called an "infusion set" that is secured to the patient's body. The connection between the insulin pump and the infusion set is now formed by a flexible infusion tube, which is detachably coupled to the infusion set by means of a coupling. Since the infusion set is practically permanently carried by the human body, it is important in such applications that the infusion set provide good carrying comfort. For this purpose, it is important to design the infusion set with the connected infusion line as flat as possible and to have as little interference with the patient's ability to move freely as possible. It is also important to realize the attachment and detachment of the infusion tube in a simple and reliable manner and to eliminate misoperation as much as possible through the structural design of the infusion set. Similar requirements and constraints exist when samples of bodily fluids are to be taken from a patient over an extended period of time.

Patent documents WO02/070037A2, DE29905068U1, US6,923,791B2, WO2005/049117A2, US2005/0101910A1 and WO2004/026375A1 disclose infusion sets, in which the infusion tube is inserted into the bearing injection cannula with an adapter along the axial direction of the injection cannula. on the device part of the tube and can be separated from the carrier part in the opposite direction. Here, the injection cannula in the infusion set described in WO02/070037A2, DE29905068U1, US6,923,791B2, WO2005/049117A2, US2005/0101910A1 and WO2004/026375A1 is provided for substantially vertical infusion into the patient's body, wherein the infusion tube Protruding sideways in a direction perpendicular to the direction of insertion of the adapter, the device disclosed in DE29905068U1 is provided for entering the body of a patient at an acute angle, wherein the infusion tube protrudes above the direction of insertion of the adapter. After being inserted on the injection cannula carrier, the adapter in devices according to WO02/070037A2, DE29905068U1, US6923791B2, WO2005/049117A2, US2005/0101910A1 can be rotated relative to the injection cannula carrier, while in WO2004/026375A1 The adapter in the disclosed device is locked relative to the cannula carrier in the selected rotational orientation during insertion.

All these known devices have the disadvantage that in order to separate the infusion tube from the infusion set, the adapter is separated from the infusion set in the axial direction of the injection cannula, so that there is the not insignificant risk that the injection cannula will slip It is completely or partially withdrawn from the insertion site, and finally it is impossible or only insufficient to realize the infusion of the medical solution into the tissue.

The infusion sets disclosed in WO02/070037A2, US6,923,791B2, WO2005/049117A2, US2005/0101910A1 and WO2004/025375A1 also have the following disadvantages, which have a relatively high structure when the infusion tube is connected, while DE29905068U1 The known device also has the disadvantage that it is no longer possible to change the direction in which the infusion tubing protrudes from the infusion set after the patient has used up the carrying part for the infusion cannula.

Contents of the invention

It is therefore the object of the present invention to provide a device for infusing fluids into and withdrawing fluids from a patient which does not have or at least partly avoids the above-mentioned disadvantages of the prior art. This task is achieved by a device according to claim 1 .

Accordingly, the device according to the invention for the infusion of fluids into or out of a patient comprises a first component having an injection cannula protruding from the first component, the injection cannula being arranged to be inserted into the placed inside the patient's body. The device also includes a second component that has an interface for detachable coupling to a corresponding coupling of a line for feeding or discharging liquid. Here, a "corresponding" coupling means a coupling which is adapted to the interface in such a way that the interface together with the coupling results in a secure, reseparatable and reconnectable plug which fits into each other -Joint points for infusion tubes in the form of sleeve connection structures. The first component and the second component of the device according to the invention are designed and connected to each other in such a way that they are inseparable and rotatable relative to each other. In addition, the first and second members form an externally closed passage between the hub and the injection cannula in each relative position that they can occupy relative to each other, by means of which passage liquid can be sent from the hub to the injection cannula or the injection cannula. From the injection cannula is fed to the port. Furthermore, the connection is designed and arranged on the second component in such a way that the connection and disconnection of the corresponding couplings of a line can only be carried out transversely to the longitudinal axis of the injection cannula.

Through the present invention, it will be possible to provide a device for infusing fluid into or outputting fluid from the patient's body. The device not only provides good carrying comfort, but also provides reliable safety against misoperation.

In a preferred embodiment of the device, the interface of the second component of the device is designed in such a way that the connection and disconnection of the corresponding coupling must always be carried out perpendicularly to the longitudinal axis of the injection cannula. This results in maximum safety against inadvertent withdrawal of the injection cannula when the coupling is uncoupled.

In a further preferred embodiment of the device, the first component and the second component are relatively rotatable about a rotation axis extending parallel to the longitudinal axis of the injection cannula. In this way a very simple construction can be achieved when the injection cannula is arranged for vertical entry into the body, which is preferred.

In another preferred embodiment of the device, the injection cannula protrudes vertically or non-perpendicularly from a substantially planar outer surface of the first member, where, in both cases, the first and second members can A relative rotation is performed about an axis of rotation perpendicular to the outer surface. This results in the advantage that the plane of rotation of the second member extends parallel to the body surface after the device has been used, with the result that essentially the same conditions of use are obtained at any rotational relative position between the first member and the second member.

In another preferred embodiment of the device according to the invention, the first and second members are rotatable through 360°, preferably continuously relative to each other, or less than 360° relative to each other, ie without continuous relative rotation. Depending on the application, one of these two variants may be advantageous, the first variant having the advantage that the second component can be placed in any position and that the first and second components can be positioned continuously opposite each other. With rotation and the device is designed accordingly, the second member can be rotated to any relative position. The latter variant has, for example, the advantage that, in the intended application, the lines connected to the device do not become entangled due to multiple rotations of the second component relative to the first component.

In another preferred embodiment of the device according to the invention, the coupling between the first member and the second member is formed such that a certain torque must be overcome in order to make the relative rotation of the two members, preferably 0.01 Nm to 0.05 Nm, better is a torque of 0.01Nm to 0.1Nm.

In this case, the following measure is preferred, in order to generate the torque to be overcome, there is provided a device with a prestressed elastic part for generating friction between the first component and the second component, in particular a prestressed elastic seal such as O O-ring and/or ratchet mechanism. The advantage of this embodiment is that it prevents undesired relative rotation of the two components, for example caused by a change of posture of the person carrying the device with respect to the direction of gravity, so that in certain embodiments of the device In this case, the previously described risk of entanglement of the infusion tubing coupled to the device can be significantly reduced. The possibility of finding the interface after temporarily disconnecting the coupling connecting the pipeline from the device can thus be improved, because the second member stays in the opposite position occupied when it is separated in the absence of force acting on it. The relative position of the first member.

In another preferred embodiment, the device has a locking mechanism designed to eliminate the possibility of relative rotation of the first and second members by locking the first and second members relative to each other in a certain relative position.

In this case, it is preferred according to a first variant that the locking mechanism is designed such that the first and second components are automatically locked relative to each other when the corresponding coupling of a line is connected to the connection of the second component. A relative position, or a relative position in which two members are locked in exactly opposite positions when the couplers are separated, and this lock can be released by coupling the corresponding coupler to the interface, for example, by means of a locking mechanism parts are moved into the unlocked position through this coupling. Such a design ensures a simple possibility of finding the interface after a temporary separation of the coupling and the device, since the second component remains in the relative position it occupied when it was separated.

According to a second variant, it is preferred that the locking mechanism is designed such that the first and second components are relatively locked in a relative position when the corresponding coupling of a line is coupled to the interface of the second component , and the lock is released by separating the coupling from the interface so that there is no locking with the coupling separated. This variant may be advantageous in cases where the desired relative position should normally be maintained, for example to prevent tubing from becoming tangled.

According to a third variant, the locking mechanism is preferably designed in such a way that it can be activated and/or deactivated by means of one or more actuating elements, wherein according to a specific variant, it is preferred that the locking mechanism can be locked without actuating the actuating elements . This results in a simple possibility of finding the connection after the coupling and the device have been temporarily separated, and will reliably prevent tangles of the connecting line. According to a particularly preferred embodiment variant, the locking mechanism can be selectively activated or deactivated by means of the actuating member, so that in each state the rotation between the first member and the second member can be permitted or inhibited as required.

In the embodiment of the device according to the invention which is equipped with a locking mechanism, the locking mechanism is preferably designed in such a way that the locking can take place in a plurality of individual positions in a form-fitting manner or in any position with a friction fit connection. Depending on the application and the structural design, one of these two variants is preferred.

In another preferred embodiment of the device according to the invention, the injection cannula is in the form of a soft injection cannula, preferably the following measures, in order to achieve penetration into the patient's tissue, the injection cannula is covered in its injection cannula channel by a A guide needle that can be removed for insertion after use is passed through. This so-called soft injection cannula is especially suitable for staying in the subcutaneous tissue of the patient for a long time, because the injection cannula is practically not disturbed at the insertion site.

In a further preferred embodiment of the device according to the invention, an adhesive layer, in particular of adhesive plaster, is present on the outer surface of the first component from which the injection cannula protrudes, for adhering the first component to the skin of the patient. The adhesive layer is now covered by a protective film which will be removed immediately before the device is used. Through such an adhesive layer, the device can be securely and comfortably fixed on the patient's skin during use.

In another preferred embodiment, the device also includes a corresponding coupling for connecting a line for the input or output of liquid, where the device preferably includes a corresponding coupling with such a line device.

A further aspect of the invention relates to the use of a device according to one of the preceding claims for the subcutaneous infusion of a medical fluid, preferably insulin, into a patient. In such applications, the advantages of the present invention are particularly evident.

Description of drawings

Further preferred embodiments of the invention result from the dependent claims and the following description with reference to the drawings, in which:

Fig. 1 is the perspective top view of the first scheme of the device of the present invention when representing the transfusion tube;

Figure 2 is a perspective top view of the device shown in Figure 1 when the infusion tube has been removed;

Fig. 3 represents the partial vertical section of the device shown in Fig. 1 along the transversal section of the transfusion tube longitudinal direction;

Fig. 4 represents device shown in Fig. 2 with the view identical with Fig. 3;

Fig. 5 is the top view of device shown in Fig. 1;

Figure 6 is a perspective view of a second member providing an interface of the device shown in Figure 1;

Fig. 7 is the perspective top view of the second embodiment of the device of the present invention in the state of use where the infusion tube has been connected;

Figure 8 is a perspective view of the device shown in Figure 7 when the infusion tube is removed;

Figure 9 represents a vertical section of the device shown in Figure 7 taken longitudinally along the delivery pipe;

Figure 10 represents the device of Figure 8 in the same view as Figure 9;

Fig. 11 is a vertical sectional view of the protective case arranged in the device shown in Fig. 7;

Figure 12 shows a vertical section of the device shown in Figure 7 just before use;

Fig. 13 is a perspective top view showing the third embodiment of the device of the present invention in the state of use where the infusion tube has been connected;

Fig. 14 is a side view of the device shown in Fig. 13 viewed from the connection direction of the infusion tube;

Fig. 15 represents the vertical section of the device shown in Fig. 13 taken longitudinally along the infusion tube;

Fig. 16 is a perspective top view showing the fourth embodiment of the device of the present invention in the use state where the infusion tube has been connected;

Figure 17 is a top perspective view of the device shown in Figure 16 with the infusion tube removed;

Fig. 18 represents the vertical section of the device shown in Fig. 16 taken longitudinally along the transfusion tube;

Fig. 19 is a perspective top view showing the fifth embodiment of the device of the present invention in the state of use where the infusion tube has been connected;

Figure 20 represents the vertical section of the device shown in Figure 19 taken longitudinally along the infusion tube;

Figure 21 is a perspective top view of a sixth embodiment of the device of the present invention in use;

Figure 22 is a top view of the device shown in Figure 21;

Figure 23 is a side view of the device shown in Figure 21;

Figure 24 represents the vertical section of the device shown in Figure 21 taken transversely along the connection direction of the infusion tube;

Figure 25 is a perspective view showing the first part of the device shown in Figure 21 carrying the injection cannula together with a portion of the locking mechanism.

Detailed ways

Figures 1 and 2 show a first preferred embodiment of the device according to the invention in the form of an infusion set in perspective top view, in Fig. 3 and 4 in partial longitudinal section, and in top view in Fig. The state (Figure 1, Figure 3 and Figure 5) that has been connected with the infusion tube, and shows the state without the infusion tube (Figure 2 and Figure 4). As can be seen from an overview of these figures, the infusion set comprises a satisfactory first member 1 with an upstanding injection cannula (not shown) on the bottom side. The underside of the first component 1 is formed by adhesive tape 12 , the adhesive side of which is covered with an adhesive tape 13 . The desired second component 3 is coupled inseparably but rotatably to the first component 1 about a vertical axis of rotation R, wherein the axis of rotation R extends along the longitudinal axis of the injection cannula. The second component 3 constitutes the interface 4 for the coupling 5 of the infusion tube 6 and cooperates with the first component 1 in such a way that the two components 1 and 3 form an external connection in each rotationally relative position that they can occupy relative to each other. A closed channel (not shown) is used to send infusion fluid from the interface 4 to the injection cannula. As for the internal structure of the infusion set not shown here, especially how the channel between the injection cannula and the interface 4 is formed by the first component 1 and the second component 3 and how the injection cannula is connected to the first component 1 For the internal structure related to the method, see the following embodiments, the structures of which are specifically shown and are also applicable to the previous embodiments.

As can be seen from an overview of Figures 3 and 4 and Figure 6 representing a perspective view of the second member 3, the second member 3 has teeth 14 pointing upwards on the top side of its radially outermost With the tube 6 coupled to the corresponding coupling 5 of the interface 4, this tooth is spring-engaged under the action of the spring force generated by the second member 3 to the corresponding, opposite tooth of the first member 1 and encircling 360° 15, as a result, when the infusion tube is not connected, the possibility of relative rotation of the two components 1 and 3 is eliminated (see FIG. 4 ). If the infusion tube 6 is coupled with its coupling 5 to the port 4 of the second component 3, it is done, for example by applying pressure with the thumb and forefinger, under the condition of elastic deformation of the locking arm, multiple locking of the coupling The arms 16 are moved one after the other, while the coupling 5 is inserted into the interface 4 in a direction perpendicular to the axis of rotation R of the two components 1 and 3 or the longitudinal axis of the injection cannula, and the locking arms 16 are subsequently locked. Let go, and as a result, the locking arms move apart from each other and abut against the locking protrusion 17 on the second member 3 under the action of the elastic pre-tension force, so that the second member 3 presses against it by the elastic force of the locking arm 16. The outer radial peripheral region arches downwards, whereby its teeth 14 disengage from the teeth 15 of the first component 1, so that the two components 1 and 3 can rotate relative to each other. At the same time, viewed from the connection direction of the coupler 5 , the locking arm 16 is locked behind the locking protrusion 17 , so that the coupler 5 will not be accidentally pulled out from the interface 4 . If the coupling 5 is detached from the infusion set by pressing its locking arm 16 again and simultaneously moving the coupling counter to the connection direction, the second component 3 itself arches upwards again in its outer radial peripheral region. , until its teeth 14 spring into engagement with the teeth 15 of the first member 1 , as a result, the two members 1 and 3 are locked in the relative position just relatively occupied.

Fig. 7 to Fig. 10 represent the second embodiment of the device of the present invention with perspective top view and longitudinal sectional view, and it becomes the form of the infusion device under the state of use, exactly, once is when infusion tube has been connected (Fig. 7 and Figure 9), once when there was no infusion tube (Figure 8 and Figure 10). As can be seen from an overview of the figures, the infusion set still has a satisfactory first component 1 with an upstanding injection cannula 2 of soft material on its bottom side. On the top side of the first component 1 there is provided a second component 3 which meets the requirements, which forms an interface 4 for connecting a corresponding coupling 5 of an infusion tube 6 for infusion. The first component 1 and the second component 3 are connected to one another in an inseparable but relatively rotatable manner about a vertical axis of rotation R, which corresponds to the longitudinal axis of the injection cannula 2 . At this time, the first member 1 and the second member 3 form a liquid-tight channel 7 at each rotational relative position that they can occupy relative to each other, for sending the infusion liquid from the interface 4 to the injection cannula 2 . As shown in particular in FIGS. 9 and 10 , the channel 7 is delimited on the interface side by a first diaphragm 18 for the fluid-tight connection of the infusion tube 6 , in that the first diaphragm is closed when the coupling 5 is connected. The infusion injection cannula seated in the coupler is pierced (not shown here, but as in Figures 15 and 18 of the following examples). The liquid-tight transition between the first member 1 and the second member 3 is achieved by means of a second septum 19 provided by the first member 1 and pierced by the injection cannula protrusion 20 of the second member 3 , The cannula projection itself extends on the axis of rotation R of the components 1 and 3 . As can be seen from an overview of Figures 11 and 12 showing a vertical section of the device shown in Figure 7 (arranged prior to use in a specific protective casing 23a and 23b), the channel 7 is directly opposite the inlet of the injection cannula 2 and Lying in the extension of the cannula channel is delimited by a further septum 21 which forms part of the top side of the second component 3 and which is pierced by the guide needle 11 in the initial state. When the infusion set is used by inserting the injection cannula 2 into the patient, the guide needle 11 supports the injection cannula 2, and the guide needle is separated from the injection cannula channel and the other septum by means of a retracting member 22 arranged at its outer end after use. 21 and separated from the infusion set.

The protective shells 23a and 23b consist of two half shells 23a and 23b which can be pushed together from the initial state shown in Figure 11, in which the infusion set is put on the market and protected. Housed in housings 23a and 23b. As can be seen, the first member 1 in this embodiment consists of a round disc 26 and a central body 27 on which the injection cannula 2 is housed and which is connected to the second member 3, the disc 26 and the central body 27 are relatively swingable in the initial state shown in FIG. 11 . The two half-shells 23a and 23b have a guide mechanism, whereby when the half-shells are pushed together, the central body 27 is swung together with the second member 3 placed thereon and the injection cannula 2 passed by the guide needle 11 until it is guided The injection cannula 2 through which the needle 11 passes projects at right angles from the housings 23 a and 23 b and from the disk 26 . In the state shown in FIG. 12 and immediately before the use of the infusion set, not only the two half-shells 23a and 23b are locked, but also the disc 26 and the central body 27 are non-detachably locked, and the shells 23a and 23b constitute the handle, which is gripped to use the infusion set and is removed from the infusion set after use in a direction opposite to the insertion direction of the injection cannula 2 , where the guide needle 11 is simultaneously withdrawn from the injection cannula 2 by means of the retracting member 22 and the other septum 21 are withdrawn and removed from the injection set.

As can be seen further from an overview of FIGS. 7 to 10 , the disc 26 of the first member 1 has at its top side peripheral border teeth 15 pointing upwards, absent the infusion tubing 6 for connecting it to the second member. 3, the protrusion formed on the bottom side of the locking rocker 24 constituted by the second member 3 engages in the tooth, so that when the infusion tube 6 is not connected The possibility of relative rotation of the two components 1 and 3 is eliminated (see Fig. 8 and Fig. 10). If the infusion tube 6 is connected with its coupling 5 to the port 4 of the second component 3, it is done so that the coupling 5 runs perpendicular to the axis of rotation R of the two components 1 and 3 or the longitudinal axis of the injection cannula 2 The direction is plugged into the interface 4, here, its locking arms 16 are locked behind a corresponding locking protrusion 25, so that the coupling 5 will not be accidentally pulled out from the interface 4, and the locking rocker The rod 24 is driven to swing through the coupling 5 . In this way, the protrusions formed on the bottom side thereof are disengaged from the teeth 15 of the first member 1, and the two members 1 and 3 can be rotated relative to each other. If the coupler 5 is separated again, for this purpose, a plurality of locking arms 16 must be moved successively by applying pressure with the thumb and forefinger, so as to break away from the locking with the locking protrusion 25, while the opposite direction of the coupler 5 along the connecting direction To break away from the infusion set, then, the locking rocker 24 swings back to its original initial position under the support of elastic force and locks the two components 1 and 3 at the rotational relative position just occupied relatively.

Figures 13 to 15 show the third embodiment of the device of the present invention, which is in the form of an infusion set and is in the use state where the infusion tube has been connected, one time is a perspective top view (Figure 13), and the other is viewed from the connection direction of the infusion tube A side view (Fig. 14), and a vertical section view (Fig. 15) along the longitudinal direction of the infusion tube. As can be seen from an overview of the figures, the infusion set has a satisfactory first component 1 consisting essentially of a round disk 26 and a central body 27 on which the injection cannula 2 is mounted. In the upper region, the central body 27 is surrounded on all sides by a suitable second component 3 which forms the interface 4 for connection to the corresponding coupling 5 of the infusion line 6 for infusion. The first component 1 and the second component 3 are connected to each other in an inseparable but relatively rotatable manner about a vertical axis of rotation R, which corresponds to the longitudinal axis of the injection cannula 2 . At this time, the first member 1 and the second member 3 form a liquid-tight channel 7 at each rotational relative position that they can occupy relative to each other, for sending infusion liquid from the interface 4 to the injection cannula 2 . As shown in FIG. 15 , the channel 7 is delimited on the interface side by a first diaphragm 18 for the liquid-tight connection of the infusion line 6 , in that the first diaphragm is placed on the coupling when the coupling 5 is connected. Pierce through the infusion injection cannula 28. The fluid-tight transition between the first component 1 and the second component 3 is achieved by means of two O-rings 31 spaced apart from each other in the longitudinal direction of the injection cannula 2 , which are formed by the central body 27 support. Between the O-rings 31 , the central body 27 has a circumferential groove 29 which is connected via a radial hole 30 to the inlet of the injection cannula. As also shown, the channel 7 is delimited directly opposite the inlet of the injection cannula 2 and in a straight line extending the channel of the injection cannula by another septum 21 constituting the top side of the central body 27 of the first member 1. part and is initially passed through by a guide needle (not shown here). During penetration into the patient, the guide needle supports the injection cannula 2 and, after use, the guide needle is withdrawn from the injection cannula channel and the septum 21 and removed from the infusion set.

As shown in Figure 13, the disk-shaped part 26 of the first member 1 has six identical groove-shaped pits 32 evenly spaced along the periphery at its top side, and the surface wheels of the pits have a radially stable shape. Changed cross section. As shown in FIG. 14 , the corresponding coupling 5 of the infusion tube 6 has a corresponding mating contour on its underside and extends over the interface 4 of the second component 3 in such a way that the coupling can only be connected between the first component 1 and the second component 3 . The interface 4 between the two components 3 is now inserted into the interface 4 in the relative position centered above one of the recesses 32. Subsequently, the components 1 and 3 are locked in the relative position just occupied by coupling The tool fits into the then recess 32 with the matching contour of its underside. In this embodiment, the first member 1 and the second member 3 can be relatively locked in six different rotational relative positions, here, the connection of the coupling 5 to the interface 4 can only be completed in one of the relative positions, so , must cause members 1 and 3 to lock in this relative position. Here too, the coupling 5 has a plurality of locking arms 16, by means of which, when the coupling is plugged into the socket 4, it snaps behind locking projections (not shown), so that the coupling is prevented from 5 is accidentally pulled out of the connection 4, and in order to separate the coupling 5 from the infusion set, these locking arms must be moved successively under the pressure of the thumb and forefinger, whereby it can be removed in the opposite direction of connection Coupling 5. If the coupling 5 is removed from the infusion set as described above, the two components 1 and 3 can be rotated relative to each other again.

Fig. 16 to Fig. 18 represent the 4th embodiment of device of the present invention, and it becomes the form of the infusion device under the state of use, once with the perspective top view representation and this moment infusion tube has been connected (Fig. 16), once with the perspective top view representation, But there is no infusion tube (FIG. 17), once shown in a longitudinal vertical section view along the connected infusion tube (FIG. 18). The infusion set shown here has a structure similar to that described above, but with the following difference. Here, the disc 26 is integrally formed with the central body 27, and on its top side, instead of along its circumference The six large dimples of the border have many identical smaller dimples 32 spaced evenly around the perimeter, resulting in a bumpy surface profile in the edge region. Also different from the above embodiments, the second member 3 has an elastic locking arm 33 here, and the locking arm abuts against the bottom of the disc 26 with the locking protrusion 34 formed on the bottom side of the infusion tube 6 when the infusion tube 6 is not connected. The dimpled surface profile and thus together with the disk form a ratchet mechanism whose effect is that, in order for the second member 3 to turn relative to the first member 1, a certain force must be applied and members 1 and 3 occupy relatively independent positions. relative position. If the corresponding coupler 5 is now plugged into the interface 4 of the second member 3 as shown in FIGS. 16 and 18 , the coupler 5 prevents the locking arm 33 from bending upwards, and the first member 1 and the second member 3 are locked. in the relative position just occupied. That is to say, in this embodiment, the first component 1 and the second component 3 are relatively locked in a plurality of independent relative positions, wherein the connection of the coupler 5 to the interface 4 can only be completed at one of the relative positions, so, necessarily This causes members 1 and 3 to lock in this relative position. In the case where the coupling 5 is not connected, the first member 1 and the second member 3 can relatively rotate against the force defined by the above-mentioned ratchet mechanism, but here they relatively occupy independent positions after the removal of the rotating force. Here, the coupling 5 also has a plurality of locking arms 16, by means of which, when the coupling is plugged into the interface 4, it snaps behind the locking projections 25, so that the coupling 5 cannot be inadvertently dislodged from the In order to separate the coupler 5 from the infusion set, the locking arms must be moved successively, whereby the coupler 5 can be taken out in the reverse direction of the connection direction. The rest of the structure of this embodiment, especially the structure related to the structural design of the channel 7 and the seals 8, 21, 31, basically corresponds to the above embodiment and is therefore not discussed in detail here. Components that are not explicitly described here but are identified with reference numerals have the same function as the components with corresponding reference numerals in the above-described embodiments.

Fig. 19 and Fig. 20 show the fifth embodiment of the device of the present invention, which is in the form of an infusion set in a state of use, and once shown in a perspective top view, at this time the infusion tube has been connected (Fig. 19), and once with the edge connected The longitudinal vertical cross-sectional view of the infusion tube is shown (Fig. 20). The infusion set shown here is identical to the previously described infusion set, with the exception that here the locking arm 33 is arranged in a circumferential position opposite the socket 4 and thus also springs back when the infusion tube 6 has been connected. Correspondingly, in this embodiment, the second member 3 can always rotate relative to the first member 1 against the force limited by the ratchet mechanism not only when the coupler 5 is connected, but also when the coupler 5 is taken out, wherein Members 1 and 3 are relatively in independent relative positions. Components that are not explicitly described here but are designated with reference numerals have the same function as components with corresponding reference numerals in the above-described embodiments.

Fig. 21 to Fig. 24 represent the sixth embodiment of the device of the present invention in the form of an infusion set in the use state where the infusion tube has been connected, once with a perspective top view (Fig. 21), once with a top view (Fig. 22), once It is shown in a side view (Fig. 23), and once it is shown in a vertical cross-sectional view along the longitudinal direction of the connected infusion tube (Fig. 24). The internal configuration of this embodiment with respect to the structural design of the channel 7 and the seals 8 , 18 and 21 corresponds substantially to the second exemplary embodiment described in conjunction with FIGS. 7 to 10 . As can be seen from an overview of FIGS. 21 to 24 , the infusion set still has a satisfactory first component 1 with a vertically protruding injection cannula 2 of soft material on its bottom side. On the top side of the first component 1 there is provided a second component 3 which meets the requirements, which forms an interface 4 for connecting a corresponding coupling 5 of an infusion tube 6 for infusion. The first component 1 and the second component 3 are coupled to one another inseparably and relatively rotatably about a vertical axis of rotation R, wherein the axis of rotation R is identical to the longitudinal axis of the injection cannula 2 . At this time, the first component 1 and the second component 3 form a liquid-tight passage 7 at each rotational relative position that they can occupy relative to each other, and are used for sending infusion fluid from the interface 4 to the injection cannula 2 . Here, the channel 7 is delimited on the interface side by a first diaphragm 18 for the liquid-tight connection of the infusion line 6 in that, when the coupling 5 is connected, the septum is placed in the infusion injection in the coupling. Cannula 28 is pierced. The fluid-tight transition between the first component 1 and the second component 3 is achieved here by means of a rubber seal 8 under compressive stress, which is penetrated by a coupling pin 9 of the second component 3 , which is itself in the component 1 and 3 on the axis of rotation R and has a hole in its center which forms part of the channel 7 . Just opposite the entrance to the hole of the pin 9 and in the prolongation of the injection cannula channel, the channel 7 is delimited by another septum 21 which forms part of the top side of the second member 3 and which in the initial state is guided towards the needle (not shown) through. When the infusion set is used by inserting the injection cannula 2 into the patient, the guide needle supports the injection cannula 2, and after use, the guide needle is released from the injection cannula channel and the other septum by means of a pull-back member installed at its outer end. 21 was withdrawn and removed from the infusion set.

As shown in particular in connection with FIG. 25 , which represents the first component 1 in a perspective view together with the operating element 10 of the locking mechanism, which will also be described in detail, the first component 1 here consists of a disc 26 and a central body 27 , which With circumferential, radially inwardly pointing internal teeth 15 , the central body protrudes upwardly beyond the disk 26 at its center. Also shown in FIG. 25 is an operating element 10 disposed between the first component 1 and the second component 3 in a circumferential position opposite the interface 4, which extends radially in the second component 3 and is The elastic tongue 35 formed by the second component 3 is pressed radially outwards under the action of the spring force, where it engages with the internal toothing 15 of the first component 1 by corresponding mating teeth (not shown) thus formed, As a result, no rotation of the two components 1 and 3 in the situation shown can occur. If the operating member 10 is pressed radially inwardly, the operating member itself overcomes the elastic force of the elastic tongue 35 and moves radially inwardly, so that the mating teeth of the operating member 10 are disengaged from the engagement with the internal teeth 15, and the second member 3 can rotate relative to the first member 1 regardless of whether the coupling 5 is connected to the interface 4 or not. If the operating part 10 is released, it is pressed outwards again by the elastic tongue 35 until the cooperating teeth of the operating part 10 engage in the internal teeth 15 of the first member 1 and the two members 1 and 3 are locked In the rotationally relative position that was just relatively occupied. Here, too, locking in a plurality of independent positions is achieved.

Claims (16)

1. A device for infusing fluid into or outputting fluid from a patient, comprising: A first member (1) having an injection cannula (2) protruding from the first member for placement in a patient; The second component (3), the second component has an interface (4) for detachably coupling a corresponding coupling (5) of a pipeline (6) for the input or output of liquid; Wherein, the first member (1) and the second member (3) are constituted and connected to each other in such a way that they are inseparable, can rotate relative to each other and form a channel (7) at each relative position for accessing from the interface (4) For feeding liquid into the injection cannula (2) or for outputting liquid from the injection cannula (2) to the interface (4), the interface (4) of the second component (3) is configured in such a way that the corresponding coupling (5 ) connection and disconnection are always done transversely along the longitudinal axis of the injection cannula (2). 2. The device according to claim 1, characterized in that the interface (4) of the second component (3) is formed such that the connection and disconnection of the corresponding coupler (5) are always perpendicular to the injection cannula (2 ) is completed on the longitudinal axis. 3. Device according to one of the preceding claims, characterized in that the first component (1) and the second component (3) can rotate about an axis of rotation extending parallel to the longitudinal axis of the injection cannula (2) ( R) rotate relative to each other. 4. Device according to one of the preceding claims, characterized in that the injection cannula (2) protrudes vertically or non-perpendicularly from a substantially flat outer surface of the first member (1), and the first member (1) and the second member (3) are rotatable relative to each other about a rotation axis (R) perpendicular to the outer surface. 5. Device according to one of the preceding claims, characterized in that the first component (1) and the second component (3) can be rotated relative to each other by 360° or by less than 360°. 6. The device according to one of the preceding claims, characterized in that the coupling between the first component (1) and the second component (3) is formed such that the relative rotation of the two components (1, 3) Instead, a certain torque must be overcome, especially a torque in the range of 0.01 Nm to 0.05 Nm and especially in the range of 0.01 Nm to 0.1 Nm. 7. The device as claimed in claim 6, characterized in that, in order to generate said torque to be overcome, there is provided a pretensioned elastic member (8, 31) between the first member (1) and the second member ( 3) Devices that generate friction between them, especially preloaded elastic seals (8, 31) and/or ratchet mechanisms. 8. The device according to any one of the preceding claims, characterized in that a locking mechanism is provided for eliminating the first Possibility of relative rotation of member (1) and second member (3). 9. The device according to claim 8, characterized in that the locking mechanism is designed in such a way that when no corresponding coupling (5) of the pipeline (6) is coupled to the interface (4) of the second component (3) , the first member (1) and the second member (3) are relatively locked in a relative position, and the locking can be released by coupling the corresponding coupler (5) to the interface (4). 10. The device according to claim 8, characterized in that the locking mechanism is designed such that when the corresponding coupling (5) of the pipeline (6) is coupled to the interface (4) of the second member (3), The first member (1) and the second member (3) are relatively locked in a relative position, said locking can be released by separating the corresponding coupling (5) from the interface (4). 11. Device according to claim 8, characterized in that the locking mechanism is designed in such a way that it can be activated or deactivated by means of one or more operating elements (10). 12. The device as claimed in one of claims 8 to 11, characterized in that the locking mechanism is designed in such a way that the locking can be realized in several independent positions by means of a positive connection or in any position by means of a frictional connection . 13. The device as claimed in one of the preceding claims, characterized in that the injection cannula (2) is a flexible injection cannula (2), in particular that the injection cannula is removable in its injection cannula channel The guide needle (11) passes through for realizing the insertion of the injection cannula (2) into the tissue of the patient. 14. Device according to one of the preceding claims, characterized in that on the outer surface of the first component (1) at which the injection cannula (2) protrudes from the first component there is a surface, in particular made of adhesive plaster (12). The adhesive layer is used to fix the first member (1) on the patient's skin by bonding. 15. The device according to one of the preceding claims, characterized in that it also comprises a corresponding coupling (5) for connecting the lines (6) for the input or output of liquid. 16. Use of the device according to one of the preceding claims for the subcutaneous infusion of a medical fluid, in particular insulin, into a patient.

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